Evaluation of Biomarkers of Exposure in Smokers Switching to a Carbon-Heated Tobacco Product: A Controlled, Randomized, Open-Label 5-Day Exposure Study

Nicotine Tob Res. 2016 Jul;18(7):1606-13. doi: 10.1093/ntr/ntw022. Epub 2016 Jan 27.


Introduction: Tobacco harm reduction aims to provide reduced risk alternatives to adult smokers who would otherwise continue smoking combustible cigarettes (CCs). This randomized, open-label, three-arm, parallel-group, single-center, short-term confinement study aimed to investigate the effects of exposure to selected harmful and potentially harmful constituents (HPHCs) of cigarette smoke in adult smokers who switched to a carbon-heated tobacco product (CHTP) compared with adult smokers who continued to smoke CCs and those who abstained from smoking for 5 days.

Methods: Biomarkers of exposure to HPHCs, including nicotine and urinary excretion of mutagenic material, were measured in 24-hour urine and blood samples in 112 male and female Caucasian smokers switching from CCs to the CHTP ad libitum use. Puffing topography was assessed during product use.

Results: Switching to the CHTP or smoking abstinence (SA) resulted in marked decreases from baseline to Day 5 in all biomarkers of exposure measured, including carboxyhemoglobin (43% and 55% decrease in the CHTP and SA groups, respectively). The urinary excretion of mutagenic material was also markedly decreased on Day 5 compared with baseline (89% and 87% decrease in the CHTP and SA groups, respectively). No changes in biomarkers of exposure to HPHCs or urinary mutagenic material were observed between baseline and Day 5 in the CC group.

Conclusions: Our results provide clear evidence supporting a reduction in the level of exposure to HPHCs of tobacco smoke in smokers who switch to CHTP under controlled conditions, similar to that observed in SA.

Implications: The reductions observed in biomarkers of exposure to HPHCs of tobacco smoke in this short-term study could potentially also reduce the incidence of cancer, cardiovascular and respiratory diseases in those smokers who switch to a heated tobacco product.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Biomarkers / blood
  • Biomarkers / urine
  • Carboxyhemoglobin / metabolism
  • Carboxyhemoglobin / urine
  • Electronic Nicotine Delivery Systems / psychology*
  • Female
  • Harm Reduction
  • Humans
  • Male
  • Middle Aged
  • Nicotine / blood
  • Nicotine / urine
  • Poland
  • Smoking / blood
  • Smoking / psychology*
  • Smoking / urine
  • Smoking Cessation / methods
  • Smoking Prevention
  • Treatment Outcome
  • Young Adult


  • Biomarkers
  • Nicotine
  • Carboxyhemoglobin